You are here

Novel anti-neuroinflammatory drug for aneurysmal subarachnoidhemorrhage (aSAH)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44NS124443-01A1
Agency Tracking Number: R44NS124443
Amount: $498,363.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 106
Solicitation Number: PA21-259
Timeline
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-18
Award End Date (Contract End Date): 2025-08-31
Small Business Information
105 AUBRUN ST
Newton, MA 02466-2524
United States
DUNS: 080178314
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 VICTOR SHIFRIN
 (617) 872-0639
 vshifrin@ic-rx.com
Business Contact
 VICTOR SHIFRIN
Phone: (617) 872-0639
Email: vshifrin@ic-rx.com
Research Institution
N/A
Abstract

ABSTRACT
Nontraumatic (aneurysmal) subarachnoid hemorrhage (aSAH) is one of the most dangerous forms of stroke,
with almost half of victims dying within the first month after diagnosis, and a half of the survivors becoming
severely disabled and incapable of living independently.
This proposal is focused on addressing a common pathophysiological mechanism of neurocognitive outcomes
of aSAH and other acute and chronic brain injuries – dysregulated overproduction of proinflammatory cytokines
in the brain. Despite advances in our understanding of molecular neuroinflammatory mechanisms underlying
adverse neuronal sequelae of acute and chronic brain injuries, approved therapeutics that target this
pathological process are lacking.
ImmunoChem Therapeutics (ICT) proposes to advance MW189, a novel small molecule anti-inflammatory
experimental drug which has already successfully completed phase 1a and phase 1b clinical trials, as a
candidate for a disease-modifying therapy for aSAH. MW189 is a selective suppressor of injury- and disease-
induced proinflammatory cytokine overproduction associated with destructive glia inflammation/synaptic
dysfunction cycles and their long-term neurotoxic effects. This proposed Fast-Track SBIR will deliver a phase
2a trial-ready drug and the corresponding regulatory documentation portfolio for a future pilot trial in aSAH.
Specifically, we will:
1. Extend preclinical efficacy and pharmacodynamic data, and obtain the dosing and drug exposure
information required to support a future phase 2a proof-of-concept clinical study in aSAH patients;
2. Produce and validate a GMP batch of the drug product from the existing cGMP drug substance (API) supply
at a qualified Contract Manufacturing Organization (CMO); and
3. Prepare and submit an amendment to the open MW189 IND for a phase 2a clinical trial in aSAH patients.
The Fast-Track structure will allow us to immediately move from proof of feasibility to SBIR Phase II activities
that flow seamlessly from preparation of the Phase 2 trial-ready drug product to essential regulatory milestones
for a future first-in-patient aSAH trial. Successful execution of the proposed project will position MW189 for
immediate entry into a pilot proof-of-concept phase 2 trial in aSAH patients that will include pharmacokinetics
and a pharmacodynamic arm. The success in that trial will, in turn, make MW189 a first-in-class drug candidate
with a potential to become a novel therapeutic approach to SAH and other acute and chronic neurological
disorders that involve dysregulated neuroinflammation as a driver of disease progression.

* Information listed above is at the time of submission. *

US Flag An Official Website of the United States Government